Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid
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ClinicalTrials.gov Identifier: NCT00729924 |
Recruitment Status
:
Completed
First Posted
: August 8, 2008
Results First Posted
: March 3, 2015
Last Update Posted
: March 3, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Raltegravir | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid |
Study Start Date : | August 2008 |
Actual Primary Completion Date : | February 2011 |
Actual Study Completion Date : | August 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Open label oral raltegravir
Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days.
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Drug: Raltegravir
400mg orally every 12 hours for 7 days
Other Name: MK-0518
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- Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Plasma Area-under-the-curve. [ Time Frame: Day 7 ]The primary outcome for this study was the ratio of the 4-hour CSF concentration value (ng/mL) to the partial plasma area-under-the-curve 0-4h value (h*ng/mL).
- Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Single Plasma Timepoint. [ Time Frame: Day 7 ]This outcome was the ratio of the 4-hour CSF concentration value (ng/mL) to the 4-hour plasma concentration value (ng/mL).

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
- Able to give informed consent.
- Negative HIV-1 serology.
- At least 18 but no more than 55 years of age.
- Body mass index <30.
- Estimated creatinine clearance ≥ 50 mL/minute within 30 days prior to study entry.
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Within 30 days prior to study entry:
- Absolute neutrophil count ≥ 1,000/mm3.
- Hemoglobin ≥ 12.5 g/dL for males and ≥ 11.5 g/dL for females.
- Platelet count ≥ 100,000/mm3.
- AST, ALT, and total bilirubin within normal range.
- Alkaline phosphatase < or = 1.5 x upper limit of normal.
- Female study volunteers of reproductive potential must have a negative serum or urine pregnancy test performed within 30 days before study entry.
- Must agree not to participate in a conception process.
- Drug transporter gene ABCB1 position 3435 genotype C/C or T/T.
Exclusion criteria:
- Use of any medication that is metabolized by CYP3A or UGT1A1.
- Anticipated need to take any medication that is metabolized by CYP3A or UGT1A1 during the study.
- Active drug use or dependence.
- Inability to abstain from alcohol-containing beverages, grapefruit, and grapefruit juice.
- Serious illness that would interfere with study participation.
- Hospitalization for any reason or therapy for serious illness within 14 days prior to study entry.
- History of hypersensitivity to study drug or its formulation.
- As determined by the investigator, a significant active or previous history of cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, or immunologic disease(s). This is inclusive of chronic illnesses such as hypertension, coronary artery disease, arthritis, diabetes, any chronic gastrointestinal conditions that may affect drug absorption, etc.
- Breast-feeding.
- Evidence of CNS infection or space occupying lesion by history or physical examination.
- History of significant CNS disorder.
- Prisoners or subjects who are compulsorily detained.
- ABCB1 position 3435 C/T heterozygosity.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729924
United States, Tennessee | |
Vanderbilt Therapeutics Clinical Research Site | |
Nashville, Tennessee, United States, 37204 |
Principal Investigator: | David W Haas, MD | Vanderbilt University Medical Center |
Publications of Results:
Responsible Party: | David Haas, Professor of Medicine, Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00729924 History of Changes |
Other Study ID Numbers: |
080536 |
First Posted: | August 8, 2008 Key Record Dates |
Results First Posted: | March 3, 2015 |
Last Update Posted: | March 3, 2015 |
Last Verified: | March 2015 |
Keywords provided by David Haas, Vanderbilt University:
Raltegravir CSF ABCB1 SNP HIV/AIDS |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |